Kelyniam Global Inc. (OTC:KLYG) Stock In Focus After Latest News
This morning, the Kelyniam Global Inc. (OTC:KLYG) stock could well be in considerable focus among investors following a significant new development from yesterday. The company, along with the makers of custom cranial implants, Finceramica, announced that the NEOS Surgery Cranial LOOP fixation system had been awarded 510 (k) clearance by the United States Food and Drug Administration. The clearance had been provided for the product to be used in conjunction with the CustomizedBone hydroxyapatite cranial implant from Finceramica.
The Cranial LOOP cranial fixation devices are a smart system made with the bio-compatible polymer PEEK-OPTIMA for the purpose of securely fixing bone flaps following craniotomies. In the news release, the company also noted that CRANIAL LOOP had been in use for more than a decade in public and private hospitals across as many as 25 nations. In 2010, CRANIAL LOOP was cleared by the FDA for the first time.
The Chief Executive Officer of Kelyniam Global, Ross Bjella, spoke about the latest developments yesterday. He stated that the approval was a significant development since it would help the company carry on with the momentum in sales that had started in the fourth fiscal quarter of 2023. In addition to the fact that it could be provided to children with low rates of infection, the CRANIAL LOOP system has also become an additional benefit for those neurosurgeons who may choose CusomizedBone for their patients.
As a company, Kelyniam is involved in the fast-paced production of customized prosthetics through the use of computer-supported design and computer-supported manufacturing. The company uses advanced medical-grade polymers in order to make those prosthetics. It is best known for the distribution, development, and manufacturing of customized maxillo-facial and cranial implants for those patients who may need them. The company works with health systems and surgeons directly.